ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model

FDA device recall Z-2326-2025 · posted 2025-08-20 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

Action taken

On July 24, 2025, firm notified physicians via Important Medical Device Information letters. The letter provides information on the management of gradually rising daily subthreshold, low-voltage shock impedance (LVSI) pattern associated with calcification of expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE defibrillation leads manufactured by Boston Scientific Corporation between 2002 to 2021. Letter includes recommendations for routine follow-ups of affected leads, and considerations to take if lead replacement is planned. The firm is not recommending any changes to the scheduled follow-up interval for patients with ePTFE lead models.

Root cause

Component design/selection

Status

Open, Classified

Product code

NVY

Quantity affected

247,702 US; 344,670 OUS

Distribution

Worldwide Distribution. US nationwide. International distribution worldwide.

Date initiated

2025-07-24

Date posted

2025-08-20

Location

Saint Paul, MN